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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG OP-TISCH SATURN SELECT 3.02; SURGICAL TABLE

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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG OP-TISCH SATURN SELECT 3.02; SURGICAL TABLE Back to Search Results
Model Number 1522235
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 05/10/2022
Event Type  Injury  
Manufacturer Narrative
The customer has had both tables since 2014 and only recently have the injuries been noted.The two tables are in different operating rooms on the gynecology service line.The customer notes when cleaning the seat section with a damp cloth post the procedure, the liquid evaporates immediately due to the extreme heat and this scenario happens one time after 10 operations.Surgical staff confirmed both tables were being used on 24v battery mode only, there was no main power cable plugged in and no audible or visual message/alerts from the devices.It is additionally noted that the customer clinic electric department checked the ground installation with no issues noted.Hillrom currently has two complaints for both or tables involved with injury.Follow-up attempts were made with the customer; however, they could not provide any further details of medical intervention, delayed/prolonged diagnosis ¿ treatment or hospitalization, total time for the procedure, cautery use, grounding pad location, new electrical equipment placed/installed in the two or rooms, if the device still overheats with use of the power cable and cleaning agent being used.Inspection of the device by a hillrom technician found no sign of damage or failure.The mechanical/ electrical table components were noted to be functioning as designed and no trace of burns or failures were identified.The inspection states the problem is 99.9% not related to the table itself except that the table could be the vessel of an electrostatic charge.Hillrom has checked the table electronics and there is no sign of failure or heat, also the electrical safety check shows no current leak in the table.The device was found to be functioning as designed; however due to the customer allegation and potential for serious injury to be involved with the patient¿s burn, hillrom is cautiously reporting this event.If new relevant information will become available a follow-up report will be submitted.
 
Event Description
It was reported by the customer that the seat section of two saturn operating tables becomes hot during use and have seriously burned several patients to their back area during gynecology surgeries.The patients are pregnant women hospitalized to give birth and between the ages of 28-40.This report was filed in our complaint handling system as complaint # (b)(4).
 
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Brand Name
OP-TISCH SATURN SELECT 3.02
Type of Device
SURGICAL TABLE
Manufacturer (Section D)
TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
carl-zeiss-strasse 7-9
saalfeld thuringen 07318
GM  07318
Manufacturer Contact
steffen ulbrich
carl zeiss strasse 7-9
saalfeld thuringen 07318
GM   07318
MDR Report Key14569706
MDR Text Key293452755
Report Number3007143268-2022-00012
Device Sequence Number1
Product Code JEA
UDI-Device Identifier00887761988316
UDI-Public887761988316
Combination Product (y/n)N
Reporter Country CodeTS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1522235
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/10/2022
Initial Date FDA Received06/01/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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